In this short video, FDA compliance attorney Lisa Capote covers key FDA compliance guidance. Watch below, then read the full transcript.
Video Transcript
Hey there. I’m Lisa Capote, an FDA compliance attorney. If you’re exporting dietary supplements from the United States, you may need an FDA export certificate — and today I’m going to explain what that is and when you need one.
An FDA export certificate, also called a Certificate to Foreign Government or CFG, is a document that the FDA issues to confirm that a product may be legally marketed in the United States. Many foreign governments require these certificates as a condition of allowing U.S.-made products to be imported into their country.
For dietary supplements, the FDA can issue a certificate confirming that the product complies with U.S. laws. The certificate typically states that the product is manufactured in a registered facility, is not subject to a pending enforcement action, and meets applicable U.S. requirements.
To obtain a certificate, you need to apply through the FDA’s electronic export certification system. The application requires information about your firm, your facility registration, your product, and the destination country.
Important: the certificate confirms U.S. regulatory status — it doesn’t mean the product meets the requirements of the destination country. You still need to verify that your product complies with the importing country’s specific regulations.
If you’re expanding into international markets and need help with export certificates or international regulatory compliance, we can help. Reach out anytime.
Have FDA compliance questions? Contact Capote Law Firm or call (786) 207-1174.